FDA Approves Deuruxolitinib for Treatment of Severe Alopecia Areata

Sun Pharmaceutical Industries Limited announced that the US Food and Drug Administration (FDA) has approved deuruxolitinib (Lesqselvi) 8 mg for adult patients with severe alopecia areata.¹

Deuruxolitinib, administered twice-per-day, is an oral selective inhibitor of Janus Kinases (JAK) JAK1 and JAK2. It functions by disrupting these pathways which are suggested to contribute to severe alopecia areata patients’ loss of hair.

“For many people with severe alopecia areata, early intervention with effective treatment is critical,” Natasha Mesinkovska, MD, PhD, associate professor and vice chair for clinical research of dermatology at the University of California, Irvine, and clinical development program investigator, said in a statement. “An oral JAK that delivers proven results will be impactful for the alopecia areata community.”

Alopecia areata is a dermatologic condition known to impact close to 700,000 people in the US, occurring when individuals’ immune systems attack their hair follicles. The condition can result in sudden loss of hair on the face, scalp, and sometimes other body areas.

Previous pooled results of both trials were presented at 2024 American Academy of Dermatology (AAD) Annual Meeting. These findings were reported by the HCPLive editorial team in March 2024.²

This new approval by the FDA was based on findings resulting from 2 multicenter, double-blind, randomized, placebo-controlled phase 3 clinical studies known as THRIVE-AA1 and THRIVE-AA2. These trials had enrolled 1,220 subjects with 50% hair loss on the scalp at minimum and for over 6 months.

These preconditions were assessed by the Severity of Alopecia Tool (SALT). THRIVE-AA1 and THRIVE-AA2 were designed to assess the drug’s efficacy among those aged 18-65 years with severe alopecia areata in the US, Europe, and Canada. Those participating in the research were randomized by the investigators to receive either 8 mg or 12 mg of deuruxolitinib or a placebo on a dosing regimen of twice-per-day over 24 weeks.

The research team determined their primary endpoint would be the achieving of a SALT score of 20 or less, suggesting substantial regrowth of subjects’ scalp hair. The average baseline SALT score was noted by the team as being around 85.9 and 87.9 for those in THRIVE-AA1 and THRIVE-AA2, respectively.

The research team noted the average percentage of scalp hair coverage among patients was only 13%, adding that following 24 weeks, more than 30% of individuals treated with deuruxolitinib succeeded in getting 80% or more hair coverage on the scalp and up to 25% regained almost all of their hair.

Only 3.1% of participants involved in the studies discontinued their treatment due to adverse reactions. The announcement by Sun Pharma highlighted that serious side effects may occur as a result of taking the drug, including malignancies, infections, gastrointestinal perforations, thrombosis, and different laboratory abnormalities, as well as potential risks of mortality and major cardiovascular issues.

The drug was noted as not being recommended for individuals who are known to be CYP2C9 poor metabolizers or for individuals taking moderate or strong CYP2C9 inhibitors.

References

1. ^{U.S. FDA Approves LEQSELVI™ (deuruxolitinib), an Oral JAK Inhibitor for the Treatment of Severe Alopecia Areata. Sun Pharmaceutical Industries Limited. July 26, 2024. https://www.prnewswire.com/news-releases/us-fda-approves-leqselvi-deuruxolitinib-an-oral-jak-inhibitor-for-the-treatment-of-severe-alopecia-areata-302207625.html. Date accessed: July 26, 2024.}
2. ^{Smith T. Two Dosing Regimens of Deuruxolitinib Led to Regrowth of Hair for Alopecia Areata. HCPLive. March 12, 2024. https://www.hcplive.com/view/two-dosing-regimens-of-deuruxolitinib-led-to-regrowth-of-hair-for-alopecia-areata. Date accessed: July 26, 2024.}